Benzinga - by Zacks, Benzinga Contributor.
Bristol Myers Squibb (NYSE: BMY) announced that the FDA will now decide on the biologics license application (BLA) for the subcutaneous formulation of Opdivo (nivolumab) on Dec 29, 2024.
The subcutaneous formulation of Opdivo is co-formulated with Halozyme's proprietary recombinant human hyaluronidase (rHuPH20). The BLA seeks approval of the same across all previously approved adult, solid tumor indications as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy combination therapy, or in combination with chemotherapy or cabozantinib.
The BLA was accepted earlier this month with a target action date of Feb 28, 2025.
The application is based on results from the phase III CheckMate -67T study evaluating subcutaneous administration of Opdivo co-formulated with rHuPH20 compared to intravenous Opdivo in patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who have received prior systemic therapy.
Per BMY, this is the first phase III study of the subcutaneous formulation of nivolumab to evaluate and demonstrate non-inferior pharmacokinetics, efficacy and consistent safety vis-a-vis its intravenous formulation (IV). The subcutaneous formulation has the potential to be the first and only subcutaneously administered PD-1 inhibitor upon potential approval.
The formulation provides physicians with the improved convenience of an injection administered in three to five minutes rather than a 30 to 60-minute infusion. The safety profile of subcutaneous nivolumab was consistent with the IV formulation.
The company's shares have lost 17.6% year to date compared with the industry's decline of 5.2%.
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Opdivo is one of the top drugs for BMY. Earlier in the month, BMY announced that a late-stage study seeking to expand the label of Opdivo in combination with Yervoy failed to meet the primary endpoint of progression-free survival in unresectable, locally advanced stage III non-small cell lung cancer.
Approval of new drugs and label expansion of existing ones are important for BMY as the company looks to expand its portfolio. Bristol-Myers reported better-than-expected first-quarter results, as adjusted loss was narrower than expected and sales beat estimates. However, the decline in Opdivo sales was a dampener.
One of the top drugs, Revlimid, is already facing generic competition, and Eliquis, too, is likely to face challenges later.
Hence, BMY is banking on Opdivo and newer drugs like Reblozyl and Opdualag to drive growth in the future.
The recent acquisitions of Mirati Therapeutics, Karuna Therapeutics, Inc., and RayzeBio should aid the company's cause, too.
Concurrent with the first-quarter earnings release, Bristol Myers also announced that it is undertaking a strategic productivity initiative that will drive approximately $1.5 billion in cost savings by the end of 2025.
Zacks Rank & a Stock to Consider Bristol Myers currently carries a Zacks Rank #3 (Hold).
A couple of better-ranked stocks from the healthcare industry are Ligand Pharmaceuticals (NASDAQ: LGND) and ALX Oncology Holdings (NASDAQ: ALXO). Both the stocks carry a Zacks Rank #2 (Buy) each at present.
In the past 30 days, the Zacks Consensus Estimate for Ligand's 2024 and 2025 earnings per share has remained constant at $4.56 and $5.20, respectively. Shares of LGND are up 22% year to date.
In the past 30 days, the Zacks Consensus Estimate for ALX Oncology's 2024 loss per share has narrowed from $3.33 to $2.89. During the same period, the consensus estimate for 2025 loss per share has narrowed from $2.85 to $2.73.
ALX Oncology beat estimates in two of the trailing four quarters, missing the mark on the other two occasions, delivering an average negative surprise of 8.83%.
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